Advanced Viral Research Corp., of Yonkers, N.Y., said the results of a randomized, controlled and blinded clinical study of Product R therapy in patients with HIV/AIDS have been published in the July/August 2002 issue of HIV Clinical Trials. The study, conducted in 1996, showed a statistically significant increase in CD4-positive lymphocytes and weight gain in treated patients, drawn from a population of patients who had received no other treatment. Also, there was a trend toward decreased numbers and severity of opportunistic infections and decreased HIV viral loads in treated patients.
Antisoma plc, of London, reported results of an independent statistical analysis refining the predicted completion time for its pivotal Phase III trial of pemtumomab in ovarian cancer. The analysis showed that completion of the SMART (Study of Monoclonal Antibody Radioimmuno-Therapy) trial is most likely to take place during the second half of 2004. The study compares survival of patients receiving standard treatment plus pemtumomab vs. standard treatment alone. The trial will finish once there have been a total of 116 deaths across both groups, the company said. Pemtumomab is based on a mouse antibody that binds specifically to an abnormal form of mucin found on the surface of tumor cells affecting the epithelium.
Aphton Corp., of Miami, filed an investigational new drug application with the FDA to study G17DT in gastroesophageal reflux disease. One of the endpoints of the study would be whether G17DT is efficacious in providing symptomatic relief to patients suffering from the disease. The company completed a Phase II trial that showed it reduced post-meal gastrin to pre-meal levels in patients immunized with G17DT.
AVAX Technologies Inc., of Kansas City, Mo., received written notification from Nasdaq formally extending through Feb. 10, 2003, the period by which the company must obtain compliance with the minimum bid requirement.
BattellePharma Inc., of Columbus, Ohio, signed an agreement with Pharmacia Corp., of Peapack, N.J., to develop an existing Pharmacia compound using BattellePharma's Mystic inhalation technology. The deal includes an up-front payment and a mutually agreed upon development plan through clinical proof of concept. BattellePharma is a privately held specialty pharmaceutical company.
Cellular Genomics Inc., of Branford, Conn., opened a 9,000-square-foot facility for small-molecule drug discovery at its headquarters. The facility will provide CGI with capabilities in medicinal and high-speed analogue chemistry, high-throughput screening, cheminformatics and structure-based drug design. The expansion complements the existing 14,000-square-foot facility and will enable the full integration of CGI's capabilities in target discovery, validation, screening and drug development, the company said.
Cypress Bioscience Inc., of San Diego, made a presentation comparing milnacipran and duloxetine in an experimental nerve injury model known as spinal nerve ligation. The study results indicated that milnacipran and duloxetine both reversed SNL-induced thermal hypersensitivity, but milnacipran was more effective. The finding was consistent with other studies indicating that drugs that interfere with the norepinephrine reuptake inhibitor, compared to drugs that interfere more with the serotonin reuptake inhibitor, have superior analgesic properties, the company said. Milnacipran is in a Phase II study in fibromyalgia syndrome.
Genentech Inc., of South San Francisco, said its board authorized the extension of its stock repurchase program for up to an additional $375 million of common stock through June 30, 2003. To date, Genentech has purchased stock at an aggregate cost of about $574 million. The board initially approved $625 million for repurchases. Genentech plans to use the repurchased stock to offset dilution caused by issuance of shares for employee stock plans.
InKine Pharmaceutical Co., of Blue Bell, Pa., said that due to recent increases in the market value of the company's common stock, it requested a hearing before the Nasdaq Listing Qualifications Panel to appeal a Nasdaq staff determination indicating the company fails to comply with the $35 million market value requirement for continued listing on the Nasdaq Small Cap Market. The company said the stock had increased 60 percent from a recent 52-week low.
Intradigm Corp., of Rockville, Md., said it demonstrated the ability to silence endogenous genes, down-regulate the encoded protein and inhibit tumor growth in tumor-bearing animals. Results demonstrating efficacy by down-regulating a tumor growth factor or its receptor in growing tumor in such as manner as to achieve efficacy will be included at a presentation in Boston this week. The company said the capability enables discovery and validation of genes and proteins for disease-controlling roles in tumor growth and thus as targets for development of inhibitor drugs.
Kosan Biosciences Inc., of Hayward, Calif., acquired an exclusive license to intellectual property owned by Eli Lilly and Co., of Indianapolis, to develop polyketides as pharmaceutical products using genetic engineering. The license includes rights to 23 issued U.S. patents and 49 issued foreign patents, as well as many pending applications. Kosan said it will use some of the technologies in its own discovery efforts and plans to partner others.
Ligand Pharmaceuticals Inc., of San Diego, said Avinza (morphine sulfate extended-release capsules) provided stable analgesia for one year without an increase in the use of rescue medicines. Data were presented at the 10th World Congress of the International Association for the Study of Pain meeting in San Diego. In a second study presented at the congress, Avinza was said to improve physical functioning, one aspect of quality of life, in patients with chronic, moderate to severe osteoarthritis pain who completed up to 30 weeks of treatment.
NeoTherapeutics Inc., of Irvine, Calif., said that going forward, the company's resources will be devoted principally to the development of its Phase III anticancer drug, satraplatin, and the seeking of out-licensing arrangements for its antipsychotic and attention-deficit drugs. The company plans a conference call Thursday to provide additional details of the restructuring.
Pharsight Corp., of Mountain View, Calif., said NV Organon, of Oss, the Netherlands, will deploy Pharsight's clinical trial modeling and simulation technology, beginning with one of Organon's specific drug candidates. Pending the outcome of the initial project, Pharsight and Organon plan to implement Pharsight processes and technology for broader use at Organon. The agreement expands an existing two-year relationship. Pharsight's stock (NASDAQ:PHST) rose 15 cents Tuesday, or 19 percent, to close at 94 cents.
ProteoTech Inc., of Kirkland, Wash., received a Phase II Small Business Innovation Research grant from the National Institute on Aging in Bethesda, Md. The $1.2 million award will fund a two-and-a-half-year drug development program for peptide inhibitors for Alzheimer's disease. It is the third Phase II SBIR grant ProteoTech has received from the institute.
Psychiatric Genomics Inc., of Gaithersburg, Md., said the Harvard Brain Tissue Resource Center at McLean Hospital in Boston will provide tissue extracts from normal control, schizophrenic and bipolar subjects. Psychiatric Genomics uses gene expression analysis of human tissues to develop small-molecule drugs to treat mental health disorders. With the tissue from HBTRC, the company will determine patterns of gene expression using microarray technology and will use the data to further its gene and drug discovery programs.
Seattle Genetics Inc., of Bothell, Wash., initiated a Phase II trial of its antibody drug conjugate product candidate, SGN-15 (cBR96-doxorubicin immunoconjugate), for patients with advanced ovarian cancer. The trial, which is expected to include 70 patients, will evaluate SGN-15 in combination with the chemotherapeutic drug, Gemzar (gemcitabine). Seattle Genetics discovers and develops monoclonal antibody-based therapeutics to treat cancer and related diseases.
TolerRx Inc., of Cambridge, Mass., and Laureate Pharma LP, of Princeton, N.J., initiated a biopharmaceutical manufacturing and services agreement for TolerRx's therapeutic monoclonal antibody pipeline. Laureate Pharma will provide purification and asceptic filling services to support TolerRx's clinical trials. Terms of the agreement were not disclosed.
Transition Therapeutics Inc., of Toronto, began a Phase I trial of its interferon-enhancing therapy, which has demonstrated in preclinical studies to be significantly more effective than interferon alone in the treatment of multiple sclerosis, the company said. Transition said the trial should be complete by year-end 2002.
X-Ceptor Therapeutics Inc., of San Diego, along with colleagues at the Howard Hughes Medical Institutes at the University of California at Los Angeles and University of Texas-Southwestern Medical Center at Dallas established a direct protective role between the liver X receptors and the pathogenesis of cardiovascular disease. Researchers demonstrated the selective loss of macrophage LXR activity significantly increased artherosclerotic lesion development. The discovery will be published online this week in the Proceedings of the National Academy of Sciences.